First read 1 What is the difference between the Federal Food, Drug, and Cosmetic Act (FD C Act), FDA regulations, and FDA guidance at https www fda gov AboutFDA Transparency Basics ucm194909 htm and 2 Contrary to Misconceptions, a Final Guidance is Not a Final Rule at https www healthlawadvisor com 2014 08 01 contrary to misconceptions a final guidance is not a final rule then give your thought on the following What purpose does Good Guidance Practices serve, and why do you think there was a need for FDA to adopt Good Guidance Practices Can you present historic evidence to support your theory What role do you think guidances have in FDA's regulatory function Give some real life examples where FDA issued a regulation, and subsequently issued guidances interpreting or clarifying the regulation, and explain why you think the guidance was necessary and whether the guidance fulfilled its intended purpose

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Question: First read: 1. What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?at https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm and 2.

First read:

1. "What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?"at

https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm

and

2. Contrary to Misconceptions, a Final Guidance is Not a Final Rule at

https://www.healthlawadvisor.com/2014/08/01/contrary-to-misconceptions-a-final-guidance-is-not-a-final-rule/

then give your thought on the following:

What purpose does Good Guidance Practices serve, and why do you think there was a need for FDA to adopt Good Guidance Practices? Can you present historic evidence to support your theory?
What role do you think guidances have in FDA's regulatory function? Give some real-life examples where FDA issued a regulation, and subsequently issued guidances interpreting or clarifying the regulation, and explain why you think the guidance was necessary and whether the guidance fulfilled its intended purpose.

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